MAUDE Adverse Event Report: STERILMED, INC. N/A; IMAGING CATHETER

Model Number R10438577

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Perforation (2513); Not Applicable (3189)

Event Date 10/26/2017

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned to the manufacturer at the time of this report.A supplemental form will be sent once the evaluation is completed if the device is returned.The device history was unable to be reviewed as no lot not was supplied by the customer for this device.Reporter phone number: (b)(6).

Event Description

It was reported that during an afib case, a pericardial effusion was noticed.No ablation was performed prior to noticing the injury.The pericardial effusion was confirmed by ice.Caller reported that the medical intervention provided was a pericardiocentesis and 1.2 liters.It was believed by the staff that the pericardial effusion was caused by human factors and that the device functioned as it should.

• Brand Name: N/A
• Type of Device: IMAGING CATHETER
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer (Section G): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth 55446
• Manufacturer Contact: jay anderson ; 5010 cheshire parkway; ste 2; plymouth, MN 55446
• MDR Report Key: 7046637
• MDR Text Key: 92587289
• Report Number: 2134070-2017-00075
• Device Sequence Number: 1
• Product Code: OWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: R10438577
• Device Catalogue Number: R10438577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2017
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 49